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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun SAFSITE Injection Sites and IV Sets

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 Class 2 Recall
B. Braun SAFSITE Injection Sites and IV Sets
see related information
Date Posted February 18, 2014
Recall Status1 Terminated on November 03, 2014
Recall Number Z-0987-2014
Recall Event ID 67236
Premarket Notification
510(K) Numbers
K022895  K060231  K760383  K904518  K942988  K943770 
K954123  K955585 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product SAFSITE® Injection Sites and IV Sets manufactured with SAFSITE® Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Code Information Catalog #351559: batch #s 0061339694, exp. 9/30/2018, 0061338909,exp. 9/30/2018, 0061333582, exp. 8/31/2018; catalog # 352016, batch # 0061326956, exp. 10/31/2018; catalog # 352079, batch #0061333591, exp. 8/31/2018; catalog #352448, batch # 0061334116, exp.9/30/2018; catalog #473017, batch #0061332459, exp. 8/31/2018; catalog # 473017, batch #061335025, exp. 9/30/2018; catalog #473309, batch #s 0061343285, exp. 10/31/2018; calatog #473309, lot #061329867, exp. 9/30/2018, 0061339741, exp. 9/30/2018, 0061333662, exp. 8/31/2018; catalog #474563, batch #s 0061338023, exp. 10/31/2018, 0061333063, exp. 8/31/2018; catalog #490028, batch # 0061324733, exp. 8/31/2018; catalog #490213, batch #s 0061330803, 9/30/2015, 0061345558, exp. 11/30/2015; catalog # SS3140, batch # 0061339123, exp. 9/30/2015; catalog #7B0110, batch #s61315790, 61315791, 61317168, 61317170, 61318428, 61318430, 61318850, 61322303,61326405, 61327038, 61330199, 61331458, all NonSterile, No Expiration Date; catalog # 7B3179, batch #s 61313363, 61314531, 61314532, 61314535, 61330221, all NonSterile, No Expiration Date; catalog #7B3240, batch #s 61324238, exp. 8/31/2018; 61329535, exp. 9/30/2018; 61336490, exp. 7/31/2018; catalog # S5401118N, batch #0061335969, Bulk Non-Sterile, No Expiration Date; and catalog #S5401150N, batch #61326267, NonSterile; No Expiration Date.
Recalling Firm/
Manufacturer
B. Braun Medical, Inc.
901 Marcon Blvd
Allentown, Pennsylvania 18109-9512
For Additional Information Contact Customer Support
610-596-2870
Manufacturer Reason
for Recall
Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.The SAFSITE¿ Injection Site is intended to provide needle free access on IV and Extension Sets.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action A recall notification letter, dated January 7, 2014, was sent to Users and distributors.
Quantity in Commerce 2,357,944
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = B. BRAUN INSTRUMENTS
510(K)s with Product Code = FPA and Original Applicant = B. BRAUN MEDICAL, INC.
510(K)s with Product Code = FPA and Original Applicant = B. BRAUN OF AMERICA, INC.
510(K)s with Product Code = FPA and Original Applicant = ELCAM MEDICAL A.C.A.L.
510(K)s with Product Code = FPA and Original Applicant = KENDALL MCGAW LABORATORIES, INC.
510(K)s with Product Code = FPA and Original Applicant = MEDICAL DEVICE CONSULTANTS, INC.
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